Voriconazole for Secondary Prophylaxis of Invasive Fungal Infections in Patients With Allogeneic Stem Cell Transplants

Prophylaxis Of Invasive Fungal Infections Clinical Trial

— VOSIFI  

Official title:

Prospective, Open-Label, Non-Comparative, Multicenter Study for the Secondary Prophylaxis of Invasive Fungal Infections (IFI) With Voriconazole in Patients With Allogeneic Stem Cell Transplants (SCT).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00143312
• Other study ID #: A1501038
• Status: Completed
• Phase: Phase 4
• First received: August 31, 2005
• Last updated: September 23, 2009
• Start date: February 2005
• Est. completion date: April 2008

Study information

• Verified date: September 2009
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial Summary

To prevent recurrence of invasive fungal infection in patients with allogeneic stem cell transplants

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: April 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with proven or probable IFI in previous 12 months receiving an allogenic stem cell transplant for any haematological disease

Exclusion Criteria:

• Pregnant or lactating women

• Severe disease other tham the underlying condition

• Active, symptomatic uncontrolled Invasive Fungal Infection

• Any evidence of active fungal disease as defined by MSG-EORTC criteria

• Concomitant use of Voriconazole 36 hours before chemotherapy until 48 hours after chemotherapy

• Other medical conditions, including HIV positive serology that would interfere with the evaluation of therapeutic response or safety of study drug

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Mycoses
• Prophylaxis Of Invasive Fungal Infections

Intervention

Drug:
• voriconazole
Voriconazole is given to patients at least 48 hours after chemotherapy

Locations

Country	Name	City	State
Belgium	Pfizer Investigational Site	Leuven
France	Pfizer Investigational Site	Creteil
France	Pfizer Investigational Site	Marseille	Cedex 09
France	Pfizer Investigational Site	Nantes
France	Pfizer Investigational Site	Pessac
France	Pfizer Investigational Site	Strasbourg
Germany	Pfizer Investigational Site	Koeln
Germany	Pfizer Investigational Site	Mainz
Germany	Pfizer Investigational Site	Wuerzburg
Portugal	Pfizer Investigational Site	Lisboa
Spain	Pfizer Investigational Site	Barcelona
Spain	Pfizer Investigational Site	Barcelona
Spain	Pfizer Investigational Site	Madrid
Sweden	Pfizer Investigational Site	Stockholm
Switzerland	Pfizer Investigational Site	CH-4031 Basel
United Kingdom	Pfizer Investigational Site	London
United Kingdom	Pfizer Investigational Site	Manchester

Sponsors (2)

Lead Sponsor	Collaborator
Pfizer	European Group for Blood and Marrow Transplantation

Countries where clinical trial is conducted

Belgium,  France,  Germany,  Portugal,  Spain,  Sweden,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of Proven or Probable Invasive Fungal Infection (IFI): Start of Prophylaxis Until 12-month Follow-up Visit		12 months	No
Secondary	Occurrence of Proven or Probable Invasive Fungal Infection (IFI): Start of Prophylaxis Until 6-month Follow-up Visit		6 months	No
Secondary	Occurrence of Proven or Probable Invasive Fungal Infection (IFI): Start of Voriconazole Prophylaxis Until End of Prophylaxis Visit		150 days	No
Secondary	Time to Occurrence of Proven or Probable Invasive Fungal Infection (IFI)		12 months	No
Secondary	Time to Occurrence of Proven or Probable New (New Pathogen) Invasive Fungal Infection (IFI)		12 months	No
Secondary	Time to Occurrence of Proven or Probable Recurrent Invasive Fungal Infection (IFI) (Same Pathogen as Previous Baseline IFI)		12 months	No
Secondary	Survival Without Proven or Probable Invasive Fungal Infection (IFI)		6 months, 12 months	No

External Links

•   To obtain contact information for a study center near you, click here.